Transluminal delivery devices and related kits and methods

ABSTRACT

Prosthesis deployment devices are disclosed herein. In some embodiments, the prosthesis deployment device comprises an elongate delivery catheter assembly configured for electrosurgery and also configured to retain and deploy a prosthesis. Kits comprising the prosthesis deployment devices with a prosthesis loaded into a prosthesis pod of the device are disclosed herein as well as methods of using the prosthesis deployment devices.

RELATED APPLICATIONS

This application claims priority to U.S. Provisional Application No.62/471,767 filed Mar. 15, 2017, and titled “Transluminal DeliveryDevices and Related Kits and Methods,” which is hereby incorporated byreference in its entirety.

TECHNICAL FIELD

This application generally relates to medical devices. Moreparticularly, this application relates to transluminal delivery devicesand related kits and methods.

BRIEF DESCRIPTION OF THE DRAWINGS

The written disclosure herein describes illustrative embodiments thatare non-limiting and non-exhaustive. Reference is made to certain ofsuch illustrative embodiments that are depicted in the figures, inwhich:

FIG. 1 illustrates an exemplary embodiment of a prosthesis deliverydevice.

FIG. 2A illustrates a close-up perspective view of the housing assemblyof the exemplary embodiment of FIG. 1 with the slide assembly fullyextended.

FIG. 2B illustrates a close-up perspective view of the housing assemblyof the exemplary embodiment of FIG. 1 with the slide assembly fullycontracted.

FIG. 3A illustrates a close-up perspective view of one embodiment of analternative slide assembly, with the slide assembly fully extended.

FIG. 3B illustrates a close-up perspective view of the alternative slideassembly embodiment of FIG. 3A when fully contracted.

FIG. 4 illustrates a cross-sectional perspective view of a rotatablemale luer lock adapter.

FIG. 5A illustrates a profile view of one embodiment of a tip electrode.

FIG. 5B illustrates a perspective view of the same embodiment of FIG. 5Awith one variation of an electrode shank shown in phantom.

FIG. 5C illustrates the embodiment of FIG. 5B with the housing retractedand the electrode shank visible.

FIG. 6 illustrates a profile view of another embodiment of a tipelectrode.

FIG. 7 illustrates a profile view of an additional embodiment of a tipelectrode.

FIG. 8 illustrates a perspective view of another embodiment of a tipelectrode.

FIG. 9A illustrates a perspective view of another embodiment of a tipelectrode.

FIG. 9B illustrates a frontal view of another embodiment of a tipelectrode.

FIG. 9C illustrates a perspective view of the embodiment of FIG. 9B.

FIG. 9D illustrates a perspective view of another embodiment of a tipelectrode.

FIG. 9E illustrates masking elements for use with the embodiment of FIG.9D.

FIG. 9F illustrates a trim device for use with the embodiment of FIGS.9D and 9E.

FIG. 9G illustrates a perspective view of another embodiment of a tipelectrode.

FIG. 9H illustrates a profile view of the embodiment of FIG. 9G.

FIG. 9I illustrates another embodiment of a tip electrode.

FIG. 9J illustrates a perspective view of another embodiment of a tipelectrode.

FIG. 9K illustrates a perspective view of the tip electrode of FIG. 9Jwith a coating.

FIG. 10A illustrates a perspective view of a prosthesis anchor.

FIG. 10B illustrates a perspective view of another embodiment of aprosthesis anchor.

FIG. 11 illustrates an enlarged view of the area 10 of FIG. 1 .

FIG. 11A illustrates a cross-sectional view taken along the line 11A ofFIG. 11 .

FIG. 11B illustrates a cross-sectional view taken along the line 11B ofFIG. 11 .

FIG. 12 illustrates one embodiment of a proximal marker.

FIG. 13 illustrates one embodiment of partial retraction of an outersheath and the resulting partial deployment of an exemplary prosthesis.

FIG. 13A illustrates a detailed breakaway view of FIG. 13 of the partialretraction of the outer sheath and the resulting partial deployment ofthe exemplary prosthesis.

FIG. 14 illustrates one embodiment of full retraction of the outersheath of FIG. 13 and the resulting full deployment of the exemplaryprosthesis.

FIG. 14A illustrates a detailed breakaway view of FIG. 14 of the fullretraction of the outer sheath and the resulting full deployment of theexemplary prosthesis.

FIG. 15 illustrates an exploded view of the housing assembly of FIG. 1 .

FIG. 16 illustrates a perspective view of the safety tabs of FIG. 1 .

FIG. 17 illustrates a close-up perspective view of another embodiment ofa prosthesis delivery device.

FIG. 17A illustrates a breakaway view of the thumbscrew from a distalview.

FIG. 17B illustrates a breakaway view of the thumbscrew from a proximalview.

FIG. 17C illustrates a breakaway cross-sectional view of the thumbscrewand a bushing.

FIG. 17D illustrates a cross-sectional view of the bushing of FIGS.17A-17C.

FIG. 18 illustrates an exploded view of a housing assembly of FIG. 17 .

FIG. 19 illustrates a perspective view of the safety buttons of FIG. 17.

FIG. 20 illustrates a breakaway view of the safety button of FIG. 17 .

DETAILED DESCRIPTION

Prosthesis deployment devices are disclosed herein. In some embodiments,the prosthesis deployment device comprises an elongate delivery catheterassembly configured for electrosurgery and also configured to retain anddeploy a prosthesis. The prosthesis deployment device may furthercomprise a housing assembly operably coupled to the delivery catheterassembly and configured to connect to an electrosurgical powergenerator. The housing assembly may comprise an actuator configured todisplace a portion of the delivery catheter assembly to deploy theprosthesis, upon actuation. The actuator may be configured forone-handed operation.

Kits comprising the prosthesis deployment devices with a prosthesisloaded into a prosthesis pod of the device are disclosed herein as wellas methods of using the prosthesis deployment devices.

It will be readily understood that the components of the embodiments asgenerally described and illustrated in the figures herein could bearranged and designed in a wide variety of different configurations.Thus, the following more detailed description of various embodiments, asrepresented in the figures, is not intended to limit the scope of thepresent disclosure, but is merely representative of various embodiments.While various aspects of the embodiments are presented in drawings, thedrawings are not necessarily drawn to scale unless specificallyindicated.

The phrases “communication with,” “engaged with,” “connected to,” and“coupled to” are used in their ordinary sense, and are broad enough torefer to any suitable coupling or other form of interaction between twoor more entities, including mechanical, electrical, magnetic,electromagnetic, fluid, and thermal interaction. Two components mayinteract with each other even though they are not in direct contact witheach other. For example, two components may be coupled to each otherthrough an intermediate component. The directional terms “proximal” and“distal” are used herein to refer to opposite locations on a componentor device. The proximal end of a component or device is defined as theend of the device closest to the practitioner when the device is innormal use by the practitioner. The distal end is the end opposite theproximal end, along the longitudinal direction of the device, or the endfarthest from the practitioner during normal use.

Turning now to the figures, FIG. 1 illustrates an exemplary embodimentof a prosthesis delivery device 100. The prosthesis delivery device 100includes an elongate delivery catheter assembly configured forelectrosurgery and also configured to retain and deploy a prosthesis.The prosthesis delivery device 100 includes a housing assembly 130operably coupled to the delivery catheter assembly 110 and configured toconnect to an electrosurgical power generator (not shown). The housingassembly 130 includes a handle assembly 150 configured to displace aportion of the delivery catheter assembly 110 to deploy the prosthesis200, upon actuation of the handle assembly 150. In the illustratedembodiment, the handle assembly 150 is configured for one-handedoperation.

FIG. 2A illustrates a close-up perspective view of the housing assembly130 with a slide assembly 131 fully extended. FIG. 2B illustrates aclose-up perspective view of the housing assembly of the exemplaryembodiment of FIG. 1 with the slide assembly 131 fully contracted. Inthe illustrated embodiment, the delivery catheter assembly 110 isconfigured for insertion in a working channel of an echoendoscope (notshown). Upon engagement with the echoendoscope (such as via rotatablemale luer lock adapter 135), the slide assembly 131 is configured toallow adjustment of the position of the delivery catheter assembly 110relative to the echoendoscope. For example, the tip electrode 170 mayonly extend slightly past the echoendoscope (referring to termination ofthe working channel) when the delivery catheter assembly 110 is fullyinserted through the working channel. The slide assembly 131 may allowsufficient movement of the tip electrode 170 (discussed in more detailbelow) to perform electrosurgery and correct placement of the deliverycatheter assembly 110 for deployment of the prosthesis 200. For example,when placing a 8 mm stent (mid-body length), the tip electrode 170 mayneed to extend 4 cm or more beyond the end of the echoendoscope.Similarly, for a 20 mm stent, the tip electrode 170 may need to extend10 cm or more beyond the end of the echoendoscope. The length of theslide assembly 131, in particular the length of the piston 133, can beselected to provide the necessary travel for the tip electrode 170beyond the end of the echoendoscope.

The slide assembly 131 may be configured such that distal movement ofthe slide assembly 131 moves the delivery catheter assembly 110 in adistal direction and proximal movement of the slide assembly 131 movesthe delivery catheter assembly 110 in a proximal direction. For example,in the embodiment illustrated in FIGS. 2A and 2B, the slide assembly 131comprises a slide handle 132 configured to slide back and forth over afixed piston 133. The slide assembly 131 also includes a thumbscrew 134.The lockable slide handle 132 is configured for one-handed operation.The slide handle 132 may include a variety of grip patterns to enhancethe ease of grip by the user. A user grasping the slide handle 132 withthe right hand (endoscopes are typically configured for left-handedoperation) can rotate the thumbscrew 134 with the user's thumb (or thumband index finger combination) to unlock the slide handle 132. The usercan then, with only one hand, slide the slide handle 132 distally overthe piston 133. The handle assembly 150 is coupled to the slide handle132, such that movement of the slide handle 132 also moves the handleassembly 150 and the delivery catheter assembly 110 coupled thereto(discussed below in relation to FIG. 14 ). The slide handle 132 canslide over the piston 133 until it is fully contracted within the slidehandle 132, such as illustrated in FIG. 2B. The slide handle 132 canalso be proximally retracted and locked into place at any juncture alongthe piston 133. It should be understood that alternative lockingmechanisms to the thumbscrew 134 are encompassed by this disclosure,such as depressible buttons and slidable switches.

A user may adjust the slide assembly 131 under endoscopicultrasonography (EUS) guidance. An advantage of one-handed operation ofthe slide assembly 132 is that a user can be watching a video screen andmeanwhile easily adjust the position of the delivery catheter assembly110 with one hand, and still have the other hand (typically the lefthand) free for endoscope-related operations.

FIGS. 3A and 3B illustrate an alternative embodiment also configured forone-handed slide adjustment. FIG. 3A illustrates a close-up perspectiveview of a housing assembly 130′ with an alternative slide assembly 131′in a fully extended state. FIG. 3B illustrates a close-up perspectiveview of the slide assembly 131′ in a fully contracted state. In thisembodiment, the slide assembly 131′ comprises a fixed handle 132′ andslidable piston 133′. The slide assembly 131′ includes a thumbscrew134′. The handle assembly 150 is coupled to the piston 133′, such thatmovement of the handle assembly 150, and the delivery catheter assembly110 coupled thereto, moves the piston 133′. A user grasping the handle132′ with the right hand can rotate the thumbscrew 134′ with the user'sthumb (or thumb and index finger) to unlock the piston 133′. The usercan then, with the same hand, grasp the handle assembly 150 and push thepiston 133′ into the handle 132′. Likewise, the same hand (or a seconduser's hand) can pull back on the handle assembly 150 to withdraw thepiston 133′ from the handle 132′ and move the delivery catheter assembly110 in the proximal direction. A difference between the slide assembly131 and the alternative slide assembly 131′ is that for the alternativeslide assembly 131′, a user must move his or her hand between unlockingthe piston 133′ and advancing or retracting the handle assembly 150.

Referring again to FIGS. 2A and 2B, in the illustrated embodiment, thehousing assembly 130 comprises a rotatable male luer lock adapter 135configured to mate with a female luer lock adapter (not shown) attachedto the working channel of the echoendoscope. The rotatable male luerlock adapter 135 secures engagement of the housing assembly 130 to theworking channel of the echoendoscope. The rotatable male luer lockadapter 135 is coupled to the piston 133.

FIG. 4 illustrates a cross-sectional perspective view of the rotatablemale luer lock adapter 135. The rotatable male luer lock adapter 135comprises a fixed shank 136 and a rotatable housing 137. The fixed shank136 has a threaded region 136 a, a proximal outer taper 136 b, and adistal outer taper 136 c. The threaded region 136 a is located proximalto the proximal outer taper 136 b and threadingly engages threads 133 aat the distal end of the piston 133. This secures the fixed shank 136 tothe piston 133. The rotatable housing 137 has a proximal inner taper 137b and a distal inner threaded collar 137 c. The proximal inner taper 137b is configured to rotate about the proximal outer taper 136 b. Thedistal outer taper 136 c is configured to mate with an inner surface ofthe female luer lock adapter (not shown). The distal inner threadedcollar 137 c is configured to mate with an outer lip of the female luerlock adapter (not shown), such that rotation of the rotatable housing137 in a clockwise direction frictionally engages the distal outer taper136 c with the inner surface of the female luer lock adapter and alsofrictionally engages the proximal outer taper 136 b with the proximalinner taper 137 b, thereby securing the rotatable housing 137. In theillustrated embodiment, the proximal outer taper 136 b and the distalouter taper 136 c have equal and opposite angles from a profileperspective. For example, the proximal outer taper 136 b and the distalouter taper 136 c may each have a 6 percent taper. The fixed shank 136and the rotatable housing 137 may be made of any material or combinationof materials suitable for the intended use. For example, metallicthreads may be used to provide sufficient strength, but rubber coversmay be used to prevent electrical conduction via the rotatable male luerlock adapter 135.

Referring to area 10 of FIG. 1 , the catheter assembly 110 includes atip electrode 170. The tip electrode 170 may be configured for monopolaror bipolar operation. In the illustrated embodiments, the tip electrode170 is configured for monopolar operation, or in other words, the tipelectrode 170 has a single active electrode and the second electrode forcompleting the circuit is a dispersive electrode (not shown) that isexternal to the prosthesis delivery device 100. Accordingly, a conductor161 (see FIG. 4 ) runs the length of the prosthesis delivery device 100,there being no need for a second conductor as in bipolar operation. FIG.15 illustrates electrical connection of the conductor 161 to anelectrical connection 162. The electrical connection 162 is configuredfor monopolar connection to an electrosurgical power generator (notshown) and may include a 3 mm or 4 mm monopolar post, for example.Likewise, if the tip electrode 170 was configured for bipolar operation,the housing may comprises an electrical connection configured forbipolar connection to the electrosurgical power generator. For example,a second conductor in addition to conductor 161 may be present.

The tip electrode 170 may be configured to quickly cut through tissuewalls, such as within about three seconds or less. The tip electrode 170may be configured to have low friction as the tip electrode 170 ispushed through tissue walls, thereby reducing the force required forpassage through the tissue walls. The surface area of the electrodeportion of the tip electrode 170 may be minimized so as to focus thecurrent density of the electrode portion.

For example, FIG. 5A illustrates a profile view of one embodiment of atip electrode 170 a. The tip electrode 170 a comprises a blunt leadingedge 172, a collar 173, and two fins 174. These portions of the tip 170a comprise the electrode portion. The tip electrode 170 a includes ahousing 175. The housing 175 includes a distal taper 176 to minimizephysical resistance as the tip electrode 170 a is pushed through tissue.The housing 175 includes step 177 that transitions the proximal end ofthe distal taper 176 to a neck 178. The housing 175 is sized andconfigured so that an outer sheath 116 (see FIG. 8 ) of the deliverycatheter assembly 110 can butt up against the step 177 and reside overthe neck 178, allowing the outer sheath 116 to be flush with the maximumouter diameter of the housing 175. The housing 175 further includes thechamfer 179 that tapers the neck 178 to a guidewire sheath 111 thatextends through the tip electrode 170 a and is flush with the leadingedge 172. The chamfer 179 at the proximal end of the tip electrode 170 areduces the likelihood of the tip electrode 170 a catching on tissue ora deployed prosthesis as the tip electrode 170 a is withdrawnpost-deployment of a prosthesis. FIG. 5B illustrates a perspective viewof the same embodiment with an electrode shank 171 shown in phantom andelectrically connected via resistance welding to the conductor 161. FIG.5C illustrates another perspective view with the housing 175 retracted,further illustrating the electrode shank 171. In FIGS. 5B and 5C, theelectrode shank 171 comprises an internal hypotube.

The blunt leading edge 172, the collar 173, and the two fins 174 may bemade of an electrically-conductive material, such as a metal. A varietyof manufacturing techniques may be used. For example, the blunt leadingedge 172 may be machined or metal injection molded and the fins 174 andthe electrode shank 171 may be stamp manufactured. The fins 174 may notbe present or any number of fins may be present, such as one to fourfins. Additionally, the fins 174 may vary in length relative to thedistal taper 176. The blunt leading edge 172, the collar 173, and thetwo fins 174 may be coated with an insulative low-friction coating, suchas polytetrafluoroethylene (PTFE) or insulative formulations ofElectroBond or VisiBond, to further focus electrical energy and furtherfocus the current density. For example, a uniform PTFE coating could beapplied; however, the coating would not coat/adhere to sharp edges,thereby focusing the electrical current at those sharp edges.Alternatively or additionally, a portion of the surface could be maskedto prevent coating adhesion. Instead of or in addition to masking,cutting surfaces could be ground or trimmed to removed coating materialfrom the cutting surfaces. Additionally, the cutting surfaces could becoated with a conductive low-friction coating, such as conductiveformulations of ElectroBond. The housing 175 may be made of a moldedinsulator, such as a ceramic. Alternatively, the housing 175 may be madeof a conductive material and coated with an insulator.

One of ordinary skill in the art, with the benefit of this disclosure,would understand that the tip electrode 170 may be designed in a numberof different ways. For example, FIG. 6 illustrates a profile view ofanother embodiment of a tip electrode 170 b. The leading edge 172 b isless blunt in this embodiment, as compared to the tip electrode 170 a.FIG. 7 illustrates a profile view of another embodiment of a tipelectrode 170 c. In this embodiment, the leading edge 172 c is sharp.FIG. 8 illustrates a perspective view of yet another embodiment of a tipelectrode 170 d. In this embodiment, the leading edge 172 d includesPTFE coated regions 172 d′ that focus the electrical current outside ofthe PTFE coated regions 172 d′. FIG. 9A illustrates a perspective viewof still yet another embodiment of a tip electrode 170 e. In thisembodiment, the leading edge 172 e occupies the majority of the distaltaper 176 e. The tip electrode 170 e may be all metal and coated with aninsulator to focus the electrical current to the outer edges of the tipelectrode 170 e.

FIGS. 9B and 9C illustrate another embodiment of a tip electrode 170 f.The tip electrode 170 f tapers distally towards a leading edge 172 f. Adistal taper 176 f forms concave regions that define fins 174 f. Threefins 174 f are depicted, but 1-3 fins 174 f may be present. The housing175 f may be metal and may be shaped, for example, by machining or metalinjection molding. The housing 175 f may be coated with an insulator,such as PTFE, and the cutting surface either exposed by machining orprotected by masking. A neck 178 f includes a proximal pocket 178 f′where the conductor 161 may be resistance welded.

FIGS. 9D-9F illustrate another embodiment of a tip electrode 170 g andalso a method of making it. A housing 175 f may be made of metal andshaped by the processes discussed above. A mask M-1 may be inserted in aproximal end of a neck 178 g. A leading edge 172 g may be inserted in amask M-2. The housing 175 g may then be coated with an insulator, suchas PTFE. The masks M-1 and M-2 may then be removed. The housing 175 gmay next be inserted in a trim device T-1 where fins 174 g are trimmedto expose the outer edges of the fins 174 g. Two fins 174 g aredepicted; however, 1-3 fins 174 g may be present. A neck 178 g includesa proximal pocket 178 g′ where the conductor 161 may be resistancewelded.

FIGS. 9G and 9H illustrate another embodiment of a tip electrode 170 h.Fins 174 h are separate from each other and are located distal to adistal taper 176 h. The fins 174 h connect to a leading edge 172 h. Thedistal taper 176 h may spread cut tissue equal to the diameter of theouter sheath 116. A housing 175 h may be made of metal and shaped by theprocesses discussed above. The housing 175 h may be coated with aninsulator, such as PTFE, and the cutting surfaces either exposed bymachining or protected by masking. Four fins 174 h are depicted;however, 1-4 fins 174 h may be present. A proximal pocket (not shown)may be present where the conductor 161 may be resistance welded.

FIG. 9I illustrates yet another embodiment of a tip electrode 170 i. Ahousing 175 i may be made of a molded ceramic. An internal metalhypotube 171 i is present inside the housing 175 i and extends distallybeyond the housing 175 i. The conductor 161 (not shown) may beresistance welded to the metal hypotube 171 i. A resistive wire 172 i iswrapped twice around the exposed portion of the metal hypotube 171 andthen helically wraps around a distal taper 176 i of the housing 175 i.The resistive wire 172 i may have a variety of diameters The resistivewire 172 i functions as the cutting surface for the tip electrode 170 i.

FIGS. 9J and 9K illustrate another embodiment of a tip electrode 170 j.The tip electrode 170 j has a housing 175 j that may include a taperedportion 176 j that tapers distally towards a leading edge 172 j and aneck portion 178 j. The tapered portion 176 j may have a conic shape.The tapered portion 176 j may include a plurality of fins 174 j thatproject radially outward from the tapered portion 176 j. Two fins 174 jare depicted, however, embodiments with additional fins are within thescope of this disclosure. The housing 175 j may be fabricated from metaland may be shaped, for example, by machining or metal injection molding.The neck 178 j may include a proximal pocket 178 j′ where the conductor161 may be resistance welded.

FIG. 9K further illustrates the tip electrode 170 k with a coating 169k. The coating 169 k may be a dielectric coating, such as ElectroBond orVisiBond. The internal surfaces of the tip electrode 170 k may be maskedduring coating to facilitate adhesive bonding. The coating may beconfigured to only coat certain portions of the tip electrode 170 k orthe tip electrode 170 k may be wholly coated and then laser ablated toremove the coating from certain portions of the tip electrode 170 k. Forexample, the leading edge 172 k, the top surface of the fins 174 k, andthe proximal pocket 178 k′ may be uncoated.

It should be understood that the tip electrodes 170 a-170 k areexemplary and do not limit the scope of this disclosure. For example,fins, if present, may extend to the distal end of the leading edge. Theleading edge may be blunt or sharp. Additionally, the various featuresof the tip electrodes 170 a-170 k may be combined together in ways notillustrated or specifically discussed herein.

FIG. 10A illustrates a first embodiment of a prosthesis anchor 180 andFIG. 10B illustrates another embodiment of a prosthesis anchor 180′. Theprosthesis anchor 180 of FIG. 10A comprises a cylindrical shape and aninternal lumen 184. The internal lumen 184 of the prosthesis anchor 180is configured to be disposed around the guidewire sheath 111. Theprosthesis anchor 180 may further include a plurality of protuberances182 that extend radially from the cylinder. The protuberances 182 areconfigured to interact with the prosthesis (200 of FIG. 11B) and securethe prosthesis (200 of FIG. 11B) within a prosthesis pod (117 of FIGS.11 and 11B) as discussed below. The protuberances 182 may have a radialheight that range from 0.005 to 0.025 inches. The protuberances 182 maybe disposed adjacent a distal end 181 of the prosthesis anchor 180and/or adjacent a proximal end 183 of the prosthesis anchor 183.Protuberances 182 along other points of the prosthesis anchor 180 arelikewise within the scope of this disclosure. In the embodiments of FIG.10B, the protuberances 182′ on the distal end 181′ are aligned with theprotuberances 182′ on the proximal end 183′ of the prosthesis anchor180′. In other embodiments, such as the embodiment of FIG. 10A, theprotuberances 182 on the distal end 181 may be misaligned with theprotuberances 182 on the proximal end 183. In some embodiments, theprotuberances 182 on each end of the prosthesis anchor 180 may be spacedequally around the circumference of the cylinder.

In some embodiments, as illustrated in FIG. 10A, there may be fourprotuberances 182, with two protuberances 182 on the distal end 181 andtwo protuberances 182 on the proximal end 183. In some embodiments, suchas shown in FIG. 10B, there may be eight protuberances 182′, with fourprotuberances 182′ on the distal end 181′ and four protuberances 182′ onthe proximal end 183′. Embodiments wherein the prosthesis anchor 180 hasmore or less than four or eight protuberances are also within the scopeof this disclosure.

As discussed previously, the guidewire sheath 111 extends to the distalend of the tip electrode 170. The guidewire sheath 111 extends theentire length of the delivery catheter assembly 110 and the housingassembly 130. In the illustrated embodiments, the housing assembly 130includes a female luer lock adapter 138 configured for allowing accessto the lumen defined by the guidewire sheath 111 (see, e.g., FIG. 2B).Referring to area 10 of FIG. 1 and corresponding FIGS. 10 and 10A, amid-sheath 112 circumscribes a proximal region 111 a of the guidewiresheath 111. The prosthesis pod 117 circumscribes a portion of a distalregion 111 b of the guidewire sheath 111. The prosthesis pod 117 isconfigured to receive a prosthesis 200 (in elongated and stretchedform). The outer sheath 116 circumscribes the mid-sheath 112 andcircumscribes the prosthesis pod 117. The outer sheath 116 istranslatable over the mid-sheath 112 and the prosthesis pod 117 so as toallow deployment of the prosthesis 200, as is discussed in more detaillater.

FIG. 11A illustrates a cross-sectional view taken along the line 11A ofFIG. 11 . In this embodiment, the mid-sheath 112 includes a second lumen115 configured to provide access for the conductor 161. The mid-sheath112 may be extruded and include a number of lumens for different uses.In some embodiments, the conductor 161 may be embedded within themid-sheath 112.

FIG. 11B illustrates a cross-sectional view taken along the line 11B ofFIG. 11 . This embodiment illustrates a cross-sectional view of theprosthesis pod 117 taken along the protrusions 182 on a proximal end 183of a prosthesis anchor 180. The prosthesis anchor 180 of this embodimentis disposed adjacent a proximal end of the prosthesis pod 117, theprosthesis anchor being disposed around the guidewire lumen 111 andwithin the outer sheath 116. The prosthesis anchor 180 (positioned onthe guidewire lumen 111) is thus disposed within the prosthesis 200 whenthe prosthesis 200 is constrained within the prosthesis pod 117. Theprotuberances 182 interact and secure the prosthesis 200 in place duringdeployment of the prosthesis 200. In some embodiments, the prosthesis200 includes a cover coupled to the braided or woven wires of theprosthesis 200 and the protuberances 182 may interact directly with thecover. For example, when the prosthesis 200 is crimped and constrainedwithin the prosthesis pod 117, portions of the cover disposed betweencells of the prosthesis 200 may bulge outward and inward giving thecrimped prosthesis 200 an uneven or bumpy inner and outer texture. Theprosthesis anchor 180 may interact with this texture and surface tosecure the prosthesis 200 with respect to the prosthesis anchor 180 andthus with respect to the guidewire lumen 111. In some embodiments, theconductor 161 may be disposed between the prosthesis anchor 180 and theprosthesis 200 along this portion of the prosthesis pod 117.

FIG. 12 illustrates an alternative embodiment where the single conductor161 extends between the outer sheath 116 and the mid-sheath 112 alongthe proximal region 111 a of the guidewire sheath 111 and then extendson an outer surface of the guidewire sheath 111 along the distal region111 b of the guidewire sheath 111. FIG. 12 further illustrates aproximal marker 113 in-line with the mid-sheath 112 and located betweena distal end of the mid-sheath 112 and a proximal end of the prosthesispod 117. The proximal marker 113 comprises a crossover channel 114between the outer surface of the proximal marker 113 and a distalsurface of the proximal marker 113. The conductor 161 transitions viathe crossover channel 114 from between the outer sheath 116 and themid-sheath 112 to the outer surface of the guidewire sheath 111. Theproximal marker 113 may be modified to mate with the second lumen 115when such an embodiment is used. The proximal marker 113 may beconfigured to provide endoscopic and/or fluoroscopic visibility to auser.

With reference to FIG. 8 , in some embodiments, the conductor 161 may behelically wrapped around the outside diameter of the guidewire sheath111. In some instances, one or more helical loops around the guidewiresheath 111 by the conductor 161 may provide compliance, allowing theassembly to flex around bends (such as when advanced within the body)without straining the conductor 161 by pulling it tight when theassembly is in a bent or curved profile. In some instances the conductor161 may comprise a litz wire. In other instances, the conductor 161 maycomprise a single filament flat wire, such as, for example, a 0.003 inchby 0.014 inch or a 0.0024 inch by 0.017 inch. A flat wire may be easierto resistance weld. The flat wire may be coated or uncoated. In someembodiments, the conductor 161 may comprise a round coated metal wire,for example, copper. The wire may be laser ablated for ease ofresistance welding. In some embodiments, the conductor 161 may include awire braid that helps increase kink resistance.

Referring back to FIG. 4 , in this embodiment, the conductor 161 isshown adjacent the guidewire sheath 111. In contrast, in the embodimentsillustrated in FIGS. 10A and 11 , the conductor 161 is separated fromthe guidewire sheath 111 by all or much of the thickness of themid-sheath 112. This may reduce capacitive coupling.

The guidewire sheath 111, the mid-sheath 112 (and proximal marker 113),and the outer sheath 116 may be made of a variety of materials. Forexample, the guidewire sheath 111 may have a three-layer constructionwith a PTFE-polyimide blend as the inner layer to provide reducedfriction with a guidewire, a polyimide middle layer to provide strengthwithout bulk, and a polyether block amide, such as Pebax, outer layer topromote adhesion to the electrode tip 170 and any over-molded features.In some embodiments, the guidewire sheath 111 may not include metallicbraiding, so as to minimize capacitive coupling with the conductor 161;however, in other embodiments, metallic braiding may be present. Themid-sheath 112 may comprise PTFE, given its high dielectric strength, soas to minimize capacitive coupling between the conductor 161 and theguidewire sheath 111 (when the mid-sheath 112 is placed between thetwo). Other options include a polyether block amide or nylon.Additionally, the materials of the mid-sheath 112 could have differentdurometers in different regions to achieve flex-zones in the deliverycatheter assembly 110. The outer sheath 116 may have a hydrophiliccoating to increase lubricity of the delivery catheter assembly 110. Theouter sheath 116 may include PTFE as an inner layer to reduce frictionand may include para-aramid fiber braid or axially-oriented fibers toreduce stretching of the delivery assembly 110. The outer sheath 116 mayalso include materials with different durometers, such as to achievesofter flex-zones. The mid-sheath 112 and the outer sheath 116 may alsonot include metallic braiding, so as to minimize capacitive coupling.

In some embodiments, the guidewire lumen 111, the mid-sheath 112, andthe outer sheath 116 may be encompassed within the housing assembly 130by a hypotube or a pair of hypotubes. In some embodiments, the hypotubemay be fabricated from stainless steel. In some embodiments, an internalhypotube may be fabricated from stainless steel and an outer hypotubemay be fabricated from a non-conductive polymer to help improve thedielectric properties. The outer hypotube may be fabricated frompolyether ether ketone (PEEK) or another suitable material. In someembodiments, the stainless steel hypotube may have a polyethyleneterephthalate (PET) or PTFE heat shrink to help improve dielectricproperties.

The proximal marker 113 may be green to provide enhanced endoscopicvisibility to the user. The distal portion of the outer sheath 116 maybe transparent other than a distal marker 116 a that may be green (suchas via a reflow process) for endoscopic visibility. The transparentdistal portion can allow for visibility of the proximal marker 113 andthe prosthesis pod 117. Metal marker bands may be swaged into or ontothe guidewire sheath 111 underneath the proximal marker 113 and thedistal marker 116 a (relative to when the outer sheath 116 is fullydistally extended, prior to deployment of the prosthesis 200) to providefluoroscopic visibility.

In use, as the outer sheath 116 is proximally retracted, the distalmarker 116 a withdraws from the electrode tip 170. As illustrated inFIG. 13 , as the outer sheath 116 is retracted about halfway, then thedistal half of the prosthesis 200 deploys, illustrated as a stent withflared ends. FIG. 13A illustrates a detailed breakaway view of theprosthesis 200 being partially deployed and the prosthesis anchor 180securing the prosthesis 200 within the prosthesis pod 117 duringdeployment. In some embodiments, the prosthesis anchor 180 may bedisposed along the flared end portion of the prosthesis 200.

As illustrated in FIG. 14 , as the outer sheath 116 is fully retracted,then the proximal half of the prosthesis 200 deploys. The proximalmarker 113 provides endoscopic and fluoroscopic visibility (whenfluoroscopy is used in addition to or instead of EUS) for the proximalend of the prosthesis pod 117. The distal marker 116 a providesendoscopic visibility for the location of the tip electrode 170 and thedistal end of the prosthesis pod 117. As the outer sheath 116 isproximally retracted, the distal marker 116 a approaches the proximalmarker 113. A user can endoscopically see the reduction in distancebetween the distal marker 116 a and the proximal marker 113, therebyproviding visual confirmation that the outer sheath 116 is retractingproperly. FIG. 14A illustrates a detailed breakaway view of the fullydeployed prosthesis 200 with the prosthesis anchor 180 no longer securedto the prosthesis 200.

The delivery assembly 110 may include additional features that are notillustrated in the figures. The prosthesis anchor 180 may comprise apliant, rigid, and/or heat-shrinkable member that grips the prosthesis200 and prevents longitudinal displacement.

Referring back to FIGS. 1-3B and 14 , the housing assembly 130 includesa first safety tab 141 and a second safety tab 142. The first safety tab141 prevents deployment of the distal portion of the prosthesis 200 bythe handle assembly 150. The second safety tab 142 prevents deploymentof the proximal portion of the prosthesis 200 by the handle assembly150. Exemplary operation of the handle assembly 150 is now described.

FIG. 15 illustrates an exploded view of the housing assembly 130. Thehandle assembly 150 includes an actuator 151, a track 152, and a sheathadapter 153. The actuator 151 is configured to pivot on portions of thehousings 140 a and 140 b, when assembled. Spring 145 engages with thehousings 140 a and 140 b and is compressed when the actuator 151 isdepressed into the housings 140 a and 140 b. The spring 145 returns theactuator 151 to its unpivoted position when the actuator 151 is nolonger depressed by a user. As the actuator 151 is depressed and pivots,it engages with the track 152 and moves the track 152 proximally (unlessthe first and second safety tabs 141 and 142 are present, as isdiscussed below). The track 152 is engaged with the sheath adapter 153.As the track 152 proximally retracts, the sheath adapter 153 is broughtwith it. The sheath adapter 153 is fixedly coupled to the outer sheath116. Proximal movement of the sheath adapter 153 brings the outer sheath116 with it. Partial retraction of the sheath adapter 153 results indeployment of the distal half of the prosthesis 200 (see FIG. 13 ).Complete retraction of the sheath adapter 153 results in full deploymentof the prosthesis 200 (see FIG. 14 ).

The first and second safety tabs 141 and 142 each include a prong 143and 144, respectively (see FIG. 16 ), configured to protrude intocorresponding holes in the track 152. When the first safety tab 141 isin place, the track 152 is unable to move proximally as the actuator 151is depressed. With the first safety tab 141 removed, the track 152 isable to proximally retract until the sheath adapter 153 engages with theprong 144 of the second safety tab 142 (which corresponds to deploymentof the distal half of the prosthesis 200). Once the second safety tab142 is removed, the sheath adapter 153 is able to fully proximallyretract (which corresponds to full deployment of the prosthesis 200).

FIG. 17 illustrates another embodiment of a prosthesis delivery device100″. The prosthesis delivery device 100″ includes an elongate deliverycatheter assembly configured for electrosurgery and also configured toretain and deploy a prosthesis. The prosthesis delivery device 100″includes a housing 130″ operably coupled to the delivery catheterassembly and configured to connect to an electrosurgical power generator(not shown). The housing assembly 130″ may include a handle assembly150″ configured to displace a portion of the delivery catheter assemblyto deploy the prosthesis, upon actuation of the handle assembly 150″.Similar to the embodiments illustrated in FIGS. 1-4 , the prosthesisdelivery device 100″ may include a slide assembly 131″, a slide handle132″, a piston 133″, thumbscrew 134″, and a female luer lock adapter138″ that may function similar to corresponding components describedpreviously. Prosthesis delivery device 100″ may further include a firstsafety button 141″ and a second safety button 142″.

FIG. 17A illustrates a breakaway view of the thumbscrew 134″ from adistal view. FIG. 17B illustrates a breakaway view of the thumbscrew134″ from a proximal view. A bushing 300 disposed within the slidehandle 132″ may be disposed around the piston 133′. The bushing 300 andthe piston 133″ may be coaxial with the slide handle 132″ and may bedisposed along the longitudinal axis of the slide handle 132″. Thebushing 300 may be configured to stabilize the piston 133″ and to keepthe piston 133″ in coaxial alignment with the slide handle 132″. Thebushing 300 extends between a proximal end 302 and a distal end 304 anddefines an internal lumen 306 configured to be disposed around thepiston 133″. The bushing 300 may further include a plurality of pads 308that project radially inward from the internal lumen 306 and the pads308 may engage with the piston 133″ to create a tight fit and/or tomaintain the coaxial alignment of the piston 133″ and the slide handle132″. The pads 308 are not configured to prevent longitudinal movementof the piston 133″ but to create a minimal clearance fit to prevent orminimize the piston 133″ from moving out of alignment with the slidehandle 132″. Thus, the pads 308 are configured to stabilize the piston133″ in coaxial alignment including during longitudinal displacement ofthe piston 133″. The pads 308 on the distal end 304 are shown in theview of FIG. 17A and the pads 308 on the proximal end are shown in theview of FIG. 17B. In some embodiments, there may be four pads 308 on theproximal end 302 and four pads 308 on the distal end. However, there maybe more or less than four pads 308 on each end. In some embodiments,there may be an unequal numbers of pads 308 on the proximal end 302compared to the distal end 304.

In some embodiments the pads 308 are equally spaced around the internalcircumference of the internal lumen 306. In some embodiments, the pads308 on the proximal end 302 and the pads 308 on the distal end 304 maybe misaligned with each other. In some embodiments, the pads 308 on theproximal end 302 and the pads 308 on the distal end 304 may be alignedwith each other.

In some of the embodiments, such as illustrated in FIG. 17B, some of thepads 308 may include a groove 310 that is centrally disposed on the pad308. The groove 310 is configured to enable a low clearance fit betweenthe pad 308 and the piston 133″ around the majority of the circumferenceof the piston 133″ while also allowing increased tolerance along partinglines or other features of the piston 133″, for example to allow greatertolerance for flashing on the piston 133″ or other manufacturingartifacts or features.

In some embodiments, such as illustrated in FIG. 17B, the piston 133″may further include a plurality of projections 350 that project radiallyoutward from a proximal end of the piston 133″. The projections 350 areconfigured to interact with the bushing 300 and prevent the piston 133″from moving too far in a distal direction relative to the slide handle132″.

FIG. 17C illustrates a breakaway cross-sectional view of the thumbscrew134″ and the bushing 300. The bushing 300 may further include aprojection 320 that extends from an outer surface of the bushing 300.The projection may include threads 322 configured to interacts withcorresponding threads 340 on the thumbscrew 134″. The projection 320 mayfurther include an internal lumen 324, such as a lumen centrallydisposed within the projection 320. The internal lumen 324 of theprojection may be in communication with the lumen 306 of the bushing300. The internal lumen 324 may include multiple narrow portions. Forexample, internal lumen 324 may include a first narrow portion 326 thatis proximal of the internal lumen 306 of the bushing 300 and a secondnarrow portion 328 that is distal of the internal lumen 306 of thebushing 300.

The thumbscrew 134″ may further include a locking feature 330. Thelocking feature may include a first end 332 and a second end 334, thefirst end 332 may be coupled to an internal surface of the thumbscrew134″. The second end 334 is engagable with the piston 133″. In use, auser may turn the thumbscrew to advance the second end 334 of thelocking feature into engagement with the piston 133″. When the lockingfeature 330 is thus engaged with the piston 133″, the locking feature330 may prevent or minimize movement of the piston 133″ relative to theslide handle 132″. The user may turn the thumbscrew in a oppositedirection to retract the locking feature 330 and disengage the lockingfeature 330 from the piston 133″ to facilitate longitudinal displacementof the piston 133″ relative to the slide handle 132″.

The locking feature 330 may further include a bulbous or bulging feature336 that bulges or projects radially outward from the locking feature330. The bulging feature 336 may be disposed between the first narrowportion 326 and the second narrow portion 328 of the internal lumen 324of the projection 320. The bulging feature 336 may thus tend to maintainthe thumbscrew 134″ coupled to the bushing 300 and to the slide handle132″ and prevent accidental uncoupling of the thumbscrew 134″ from thebushing 300 and the slide handle 132″. In other words, the thumbscrew134″ may be rotated such that the thumbscrew 134″ allows forlongitudinal displacement of the piston 133″ and the bulging feature 336prevents the thumbscrew 134″ from falling off or otherwise decouplingfrom the entire assembly. The thumbscrew 134″ may be uncoupled from thebushing and the slide handle 132″ if a sufficient force is applied todisplace the bulging feature 336 past the second narrow portion 328 ofthe internal lumen 324 of the projection 320.

FIG. 17D illustrates a perspective cross-sectional view of the bushing300. The pads 308 are shown extending in the longitudinal direction ofthe bushing 300. The length of the pads in the longitudinal directionmay vary. In some embodiments, the pads 308 interface with the piston133″, but the internal lumen 306 does not directly contact or interfacewith the fixed piston. Groove 310 of some of the pads 308 extendlongitudinally as well.

FIG. 18 illustrates an exploded view of the housing assembly 130″. Thehandle assembly 150″ includes an actuator or lever 151″, a track 152″,and a sheath adapter 153″. The actuator 151″ is configured to pivotabout a pivot point when actuated. A spring 145″ may engage with theactuator 151″ when the actuator 151″ is depressed. The spring 145″ mayreturn the actuator 151″ to its unpivoted position when the actuator151″ is no longer depressed by a user. As the actuator 151″ is depressedand pivots, it engages with the track 152″ and moves the track 152″proximally (unless the first and second safety buttons 141″ and 142″ arenot pressed, as is discussed below). The track 152″ may be engaged withthe sheath adapter 153″. As the track 152″ proximally retracts, thesheath adapter 153″ may thus follow with it. The sheath adapter 153″ isfixedly coupled to the outer sheath 116″. Proximal movement of thesheath adapter 153″ therefore results in proximal movement of the outersheath 116″. Partial retraction of the sheath adapter 153″ results indeployment of the distal half of the prosthesis. Complete retraction ofthe sheath adapter 153″ results in full deployment of the prosthesis.

The first and second safety buttons 141″ and 142″ illustrated in FIGS.19 and 20 are non-detachable push buttons configured to interact withthe sheath adapter 153″ when the first and second safety buttons 141″and 142″ are not pressed. The first and second safety buttons 141″ and142″ each include a protrusion 143″ and 144″, respectively. Theprotrusions 143″ and 144″ are configured to interact with the sheathadapter 153″. When the first safety button 141″ is not pressed, thesheath adapter 153″ is unable to move proximally when the actuator 151″is depressed. When the first safety button 111″ is pressed, the firstsafety button 141″ slides in a direction orthogonal to the longitudinaldirection of the prosthesis delivery device 100″ and the protrusion 143″is configured to no longer engage with the sheath adapter 153″. With thefirst safety button 141″ engaged, the sheath adapter 153″ is able tomove proximally when the actuator 151″ is depressed and until the sheathadapter 153″ engages with the protrusion 144″ of the second safetybutton 142″ (which corresponds to the deployment of the distal half ofthe prosthesis). When the second safety button 142″ is pressed, thesecond safety button 142″ slides in a direction orthogonal to thelongitudinal direction of the prosthesis delivery device 100″ and theprotrusion 144″ is configured to no longer engage with the sheathadapter 153″. With the second safety button 142″ pressed, the sheathadapter 153″ is able to move proximally when the actuator 151″ is ableto fully proximally retract (which corresponds to the full deployment ofthe prosthesis).

One of the benefits of the illustrated embodiments of the prosthesisdelivery device 100 is that the handle assembly 150 may be completelyoperated with one hand, including removal of the first and second safetytabs 141 and 142.

In the illustrated embodiment, it is not possible to depress theactuator 151 when the first safety tab 141 is in place. In otherembodiments, the handle assembly 150 may be configured such thatdepressing the actuator 151 is possible, but has no effect unless thefirst safety tab 141 is removed. Additionally, in the illustratedembodiment of FIG. 15 , the track 152 is configured so that each fullratchet of the track 152 by the actuator 151 retracts the outer sheath116 about 1 cm. In some embodiments, the track 152 may be modified toprovide much smaller increments of movement over an entire depression ofthe actuator 151 or to provide small movements of the outer sheath 116as the actuator 151 is partially depressed. For example, a full ratchetmay retract the outer sheath 116 about 1 cm, but partial ratchet maymove the outer sheath 116 in 2 mm increments until it reaches a fullratchet and movement of 1 cm. This may enable the user to have greaterprecision when deploying the prosthesis. It should be understood thatthe illustrated embodiment is just one approach to proximally retractingthe outer sheath 116. One of ordinary skill in the art, with the benefitof this disclosure, would understand that a number of approaches may beused for retracting the outer sheath 116.

It should be understood that the prosthesis delivery device 100 willnormally be supplied as a kit with a prosthesis, such as the prosthesis200, loaded into the prosthesis pod 117; however, that may not always bethe case.

The prosthesis delivery devices disclosed herein may be used for avariety of procedures. For example, any time it is desirable to deploy aprosthesis in two stages, but with only one-hand, then it may bebeneficial to use the prosthesis delivery devices disclosed herein. Forexample, the prosthesis delivery devices disclosed herein may be usedfor draining one lumen of a patient into another lumen of a patient,such as, for example, transgastric or transduodenal drainage of apancreatic pseudocyst, of a biliary tract, of a gallbladder. An accessport may be created with the tip electrode between a first lumen of thepatient and a second lumen of the patient. The first lumen may be thegastrointestinal tract (for example, the esophagus, stomach, pylorus, orbowel) of the patient. The second lumen may be the gallbladder, apancreatic cyst, a biliary tract, or some other lumen that needsdrainage.

For example, draining a target structure of a patient may includeintroducing an echoendoscope into the gastrointestinal tract of thepatient with the terminal end in the vicinity of the target structure. Aguidewire may be inserted through the working channel of theechoendoscope into the target structure. The delivery catheter assembly110 (with a prosthesis loaded into the prosthesis pod 117) may then beslid over the guidewire and into the working channel of theechoendoscope. Alternatively, a guidewire may not be present, andinstead the location of the terminal end of the echoendoscope issufficiently precisely positioned near the target structure so as toguide placement of the delivery catheter assembly 110. The housingassembly 130 may be secured to the echoendoscope. The tip electrode 170may extend just beyond the terminal end of the echoendoscope. When usingthe housing assembly 130, with one-hand, while watching the endoscopevideo screen, the user may unlock the handle 132, energize the tipelectrode 170 (such as by depressing a foot pedal connected to theelectrosurgical power generator), slide the handle 132 distally untilthe target structure has been penetrated and an access port created. Theelectrode tip 170 may then be deenergized (such as by releasing the footpedal). The handle 132 may then be locked in place with the same hand.With the same hand as before, the first safety tab 141 may be removedfrom the housing assembly 130. With the same hand the actuator 151 maythen be depressed and thereby deploy the distal end of the prosthesis inthe target structure of the patient. With the same hand, the housingassembly 130 may be retracted proximally (and thereby the entiredelivery catheter assembly 110 and the partially deployed prosthesis) toconfirm visually either endoscopically, fluoroscopically, or viaultrasound that the distal end of the prosthesis is secured against thetissue wall inside the target structure. With the same hand the secondsafety tab 142 may then be removed from the housing assembly 130. Withthe same hand the actuator 151 may again be depressed and thereby deploythe proximal end of the prosthesis in the gastrointestinal tract of thepatient. With the same hand the handle 132 may be unlocked andproximally retracted to withdraw the electrode tip 170 from the targetstructure. The prosthesis, such as the prosthesis 200, can now allowdrainage of the target structure.

Any methods disclosed herein include one or more steps or actions forperforming the described method. The method steps and/or actions may beinterchanged with one another. In other words, unless a specific orderof steps or actions is required for proper operation of the embodiment,the order and/or use of specific steps and/or actions may be modified.Moreover, only a portion of a method described herein may be a separatemethod. Stated otherwise, some methods may include only a portion of thesteps described in a more detailed method.

Reference throughout this specification to “an embodiment” or “theembodiment” means that a particular feature, structure or characteristicdescribed in connection with that embodiment is included in at least oneembodiment. Thus, the quoted phrases, or variations thereof, as recitedthroughout this specification are not necessarily all referring to thesame embodiment.

Similarly, it should be appreciated that in the above description ofembodiments, various features are sometimes grouped together in a singleembodiment, figure, or description thereof for the purpose ofstreamlining the disclosure. This method of disclosure, however, is notto be interpreted as reflecting an intention that any claim require morefeatures than those expressly recited in that claim. Rather, as thefollowing claims reflect, inventive aspects lie in a combination offewer than all features of any single foregoing disclosed embodiment.Thus, the claims following this Detailed Description are herebyexpressly incorporated into this Detailed Description, with each claimstanding on its own as a separate embodiment. This disclosure includesall permutations of the independent claims with their dependent claims.

Recitation in the claims of the term “first” with respect to a featureor element does not necessarily imply the existence of a second oradditional such feature or element. It will be apparent to those havingskill in the art that changes may be made to the details of theabove-described embodiments without departing from the underlyingprinciples of this disclosure.

The invention claimed is:
 1. A prosthesis deployment device comprising:an elongate delivery catheter assembly configured for electrosurgery andalso configured to retain and deploy a prosthesis; a housing assemblyoperably coupled to the delivery catheter assembly and configured toconnect to an electrosurgical power generator, wherein the housingassembly comprises: an actuator configured to proximally displace aportion of the delivery catheter assembly to deploy the prosthesis, uponactuation, and wherein the actuator is configured for one-handedoperation, a track configured to be moved proximally by the actuatorwhen the actuator is depressed and pivots on portions of the housingassembly, a sheath adapter configured to be moved proximally by thetrack, wherein the sheath adapter is configured to displace the portionof the delivery catheter, a slide assembly comprising a handle andpiston, the slide assembly configured to adjust a position of thedelivery catheter assembly relative to an echoendoscope, wherein thedelivery catheter assembly is configured for insertion in a workingchannel of the echoendoscope and wherein the slide assembly comprises arotatable male luer lock adapter configured to mate with a first femaleluer lock adapter attached to a working channel of the echoendoscope, aproximal end of the female luer lock adapter being threadingly coupledto the slide assembly, and a first safety button and a second safetybutton, wherein the first safety button comprises a first protrusionconfigured to engage the sheath adapter to prevent deployment of adistal portion of the prosthesis, and wherein the second safety buttoncomprises a second protrusion configured to engage the sheath adapter toprevent deployment of a proximal portion of the prosthesis.
 2. Theprosthesis deployment device of claim 1, wherein the rotatable male luerlock adapter comprises a fixed shank and a rotatable housing, the fixedshank comprising a proximal outer taper and a distal outer taper, therotatable housing comprising a proximal inner taper and a distal innerthreaded collar, the proximal inner taper configured to rotate about theproximal outer taper of the fixed shank, wherein the distal outer taperis configured to mate with an inner surface of the female luer lockadapter and wherein the distal inner threaded collar of the rotatablehousing is configured to mate with an outer lip of the female luer lock,such that rotation of the rotatable housing in a clockwise directionfrictionally engages the distal outer taper of the fixed shank with theinner surface of the female luer lock adapter and also frictionallyengages the proximal outer taper of the fixed shank with the proximalinner taper of the rotatable housing.
 3. The prosthesis deploymentdevice of claim 1, wherein the delivery catheter assembly comprises atip electrode configured for bipolar operation, wherein the housingcomprises an electrical connection configured for bipolar connection tothe electrosurgical power generator, and further comprising conductorsthat electrically couple the tip electrode to the electrical connectionof the housing.
 4. The prosthesis deployment device of claim 1, whereinthe delivery catheter assembly comprises a tip electrode configured formonopolar operation, wherein the housing comprises an electricalconnection configured for monopolar connection to the electrosurgicalpower generator, and further comprising a conductor that electricallycouples the tip electrode to the electrical connection of the housing.5. The prosthesis deployment device of claim 4, wherein the conductorextends through a separate lumen of an outer sheath of the deliverycatheter assembly along a proximal region of the delivery catheterassembly.
 6. The prosthesis deployment device of claim 4, wherein thedelivery catheter assembly comprises: a guidewire sheath that forms aguidewire lumen, the guidewire sheath connected to the tip electrode; amid-sheath circumscribing a proximal region of the guidewire sheath; aprosthesis pod region circumscribing a portion of a distal region of theguidewire sheath, the prosthesis pod region configured to receive theprosthesis in elongated form; and an outer sheath circumscribing themid-sheath and circumscribing the prosthesis pod region, wherein theouter sheath is translatable over the mid-sheath and the prosthesis podregion so as to allow deployment of the prosthesis; and wherein theconductor extends between the outer sheath and the mid-sheath along theproximal region of the guidewire sheath and then extends on an outersurface of the guidewire sheath along the distal region of the guidewiresheath.
 7. The prosthesis deployment device of claim 4, wherein the tipelectrode comprises a non-conductive housing and a conductive hypotubesurrounded by the housing, wherein the conductive hypotube iselectrically-connected to the conductor and electrically connected toone or more cutting surfaces of the tip electrode.
 8. The prosthesisdeployment device of claim 4, wherein the tip electrode comprises aconductive housing that also provides one or more cutting surfaces,wherein the housing is electrically-connected to the conductor.
 9. Theprosthesis deployment device of claim 4, wherein the tip electrodecomprises either a blunt configuration or a distally-taperingconfiguration.
 10. The prosthesis deployment device of claim 1, whereinthe housing assembly further comprises a second female luer lock adapterconfigured for allowing access to the guidewire lumen.
 11. A kitcomprising the prosthesis deployment device of claim 1 and a prosthesisloaded into the prosthesis pod region.
 12. A method of deploying aprosthesis in a patient, the method comprising: inserting a deliverycatheter assembly into a working channel of an echoendoscope, whereinthe delivery catheter assembly comprises a prosthesis loaded into aprosthesis pod region; coupling the delivery catheter assembly with aworking channel of the echoendoscope via a rotatable luer lock adapter,wherein a proximal end of the rotatable luer lock adapter is threadinglycoupled to a slide assembly of the delivery catheter assembly; adjustinga position of the delivery catheter assembly relative to theechoendoscope with the slide assembly; engaging with one-hand a firstsafety button on a housing assembly to disengage a protrusion of thefirst safety button from a sheath adapter, prior to actuating with thesame one-hand an actuator to deploy a distal end of the prosthesis;actuating with the same one-hand the actuator of the housing assemblyoperably connected to the delivery catheter assembly and therebydeploying the distal end of the prosthesis in the patient, wherein theactuator is depressed and pivots on portions of the housing assembly tomove a track proximally and the track moves a sheath adapter proximally;engaging with the same one-hand a second safety button on the housingassembly to disengage a protrusion of the second safety button from thesheath adapter, prior to actuating with the same one-hand the actuatorto deploy a proximal end of the prosthesis; and actuating with the sameone-hand the actuator of the housing assembly and thereby deploying theproximal end of the prosthesis in the patient.
 13. The method of claim12, further comprising pushing with the same one-hand, a tip of thedelivery catheter assembly and a distal portion of the prosthesis podregion into a target structure, prior to actuating with the sameone-hand the actuator to deploy the distal end of the prosthesis. 14.The method of claim 13, wherein the tip comprises an electrode andfurther comprising energizing the electrode prior to pushing the tipinto the target structure and then de-energizing the electrode afterpenetrating the target structure.